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Authorized generics are prescription drugs produced by brand pharmaceutical companies and marketed under a private label, at generic prices. Authorized generics compete with generic products in that they are identical to their brand counterpart in both active and inactive ingredients; [1] whereas according to the U.S. Food and Drug Administration's Office of Generic Drugs, generic drugs are ...
At steady state, the systemic exposure for armodafinil is 1.8 times the exposure observed after a single dose. The concentration-time profiles of the (R)-(−)-enantiomer following a single dose of 50 mg Nuvigil or 100 mg Provigil (modafinil being a 1:1 mixture of (R)-(−)- and (S)-(−)- enantiomers
Modafinil, sold under the brand name Provigil among others, is a central nervous system (CNS) stimulant and eugeroic (wakefulness promoter) medication used primarily to treat narcolepsy, [3] [8] [15] a sleep disorder characterized by excessive daytime sleepiness and sudden sleep attacks. [16]
An Abbreviated New Drug Application (ANDA) is an application for a U.S. generic drug approval for an existing licensed medication or approved drug. The ANDA is submitted to FDA's Center for Drug Evaluation and Research, Office of Generic Drugs, which provides for the review and ultimate approval of a generic drug product. Once approved, an ...
Marketing Authorisation Application (MAA) is an application submitted by a drug manufacturer seeking marketing authorisation, that is permission to bring a medicinal product (for example, a new medicine or generic medicine) to the market.
A new drug application in the 1930s for sulfapyridine to the United States Food and Drug Administration. The Food and Drug Administration's (FDA) New Drug Application (NDA) is the vehicle in the United States through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing.
The list is ordered alphabetically according to the condition or conditions, then by the generic name of each medication. The list is not exhaustive and not all drugs are used regularly in all countries. Some medications treat multiple conditions and appear multiple times.
Celexa – an antidepressant of the SSRI class; Centrax – an anti-anxiety agent; Clozaril – atypical antipsychotic used to treat resistant schizophrenia; Concerta (methylphenidate) – an extended release form of methylphenidate